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A Study To Determine The Optimum Serum IGF-I Range In Patients With Acromegaly Treated With Pegvisomant - Optimum IGF1 in Acromegalic Patients on Pegvisomant

A Study To Determine The Optimum Serum IGF-I Range In Patients With Acromegaly Treated With Pegvisomant - Optimum IGF1 in Acromegalic Patients on Pegvisomant

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003741-33-GB
Enrollment
12
Registered
2007-11-26
Start date
2007-12-17
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly

Interventions

Trade Name: Somavert Pharmaceutical Form: Powder and solvent for solution for injection

Sponsors

Barts and the London NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Active acromegaly on pegvisomant monotherapy at a stable dose with a normal age-adjusted serum IGF-I for at least 3 months Over 18 years of age Willing to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Unwilling or unable to provide informed consent Other conditions known to alter IGF-I levels (severe hepatic disease, severe renal disease, malnutrition, ethanol and drug abuse) Abnormal liver enzymes Pregnancy/lactation

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine the optimum range of serum IGF1 that is to be used as a target for treatment of acromegaly with pegvisomant.;Secondary Objective: ;Primary end point(s): The study will conclude when all patients have completed 12 weeks with a subnormal IGF1 and have repeated all the measurements required.

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026